PATIENT INFORMATION LEAFLET

Please read this carefully. This leaflet provides a summary of the information about this medicine. If you have any questions or are not sure about anything you should ask a doctor, nurse or pharmacist.

The name of this medicine is Levophed Injection. Its active ingredient is noradrenaline.

Each vial of Levophed contains 0.2% w/v Noradrenaline Acid Tartrate USP equivalent to 0.t% w/v (1 :1,000) Noradrenaline. It also contains sodium metabisulphite, sodium chloride and water. Levophed is supplied in vials of 2ml, 4ml or 20ml. The 2ml and 4ml vials are supplied in cartons of 6 and the 20ml vials are supplied in cartons of 5.

Levophed is used to increase blood pressure.

The Product Licence holder is:

Sanofi Winthrop Ltd

One Onslow Street

Guildford

Surrey

GU1 4YS

The manufacturer is:Sanofi Winthrop Ltd Edgefield Avenue Fawdon Newcastle upon Tyne NE3 3TT

Levophed is used as an emergency me _ < C m w > > _ pressure has fallen danoerousiv low

Levophed should not be given to patients being given cyclopropane or halothane (which are general anaesthetics) or patients with blood gas problems eg. Iow blood oxygen levels. Special care is needed in the elderly, those with blood clots and in patients who have recently had a heart attack or who have some types of angina (chest pain). If Levophed is given during pregnancy there may be risks to the unborn baby - discuss this with your doctor. Care is also needed in patients taking monoamine oxidase inhibitors or tricyclic antidepressants (used to treat depression).

Levophed is given directly into the blood stream using a drip (or central line). This medicine is usually given diluted in a sugar (5% dextrose) solution. The usual dose is between 0.8mg and 1 .6mg every hour and is measured by a drip counter or some form of pump. The correct dose and dilution for you will have been decided by the doctor and will depend on your condition.

Your blood pressure and pulse will be monitored whilst you are receiving Levophed. Levophed may cause problems in some people. It can cause high blood pressure; headaches; poor blood flow to the hands and feet and problems with the rhythm of the heart. It may also cause pain, redness and swelling around the giving needle. You should tell your doctor or a nurse if you experience any of these or other problems.

This medicine should not be used after the expiry date which is on the pack. This medicine should be stored below 25'C in the dark.

Date of last revision June 1994. This leaflet does not contain all the information about your medicine. Pharmaceutical companies are not able to discuss your personal medical case. If you have any questions or are not sure about anything ask your doctor or pharmacist.

Levophed is a registered trademark. 1994 Sanofi Winthrop Ltd. 312/084